early feasibility evaluation of the accucinch® ventricular restoration system in patients with heart failure and reduced ejection fraction

Conditions: Heart Failure; Cardiomyopathy, Dilated

Summary: this is a non-randomized, prospective, multi-center early feasibility study to evaluate the accucinch® ventricular restoration system in patients with heart failure and reduced ejection fraction (hfref).

device name changed from accucinch® ventricular repair system to accucinch® ventricular restoration system, fda approval date 08aug2020.

Eligibility criteria:
inclusion criteria: * study patient is at least 18-years old * ejection fraction: ≥20 and ≤40% * lv end-diastolic diameter ≥55 mm * symptom status: nyha iii-iv (i.e., ambulatory) * treatment and compliance with optimal guideline directed medical and device-based therapies for heart failure (unless contraindicated or intolerant) for at least 3 months and stable doses for 1 month with stable defined as no more than 100% increase or 50% decrease of total daily doses. * patients with left bundle branch block pattern and qrs duration \>150ms are required to have a crt device for at least 3 months * patients required to have an icd are required to have icd implant at least 1 month prior to enrollment * able and willing to complete all qualifying diagnostic and functional tests and agrees to comply with study follow-up schedule exclusion criteria: * myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 3 months * mitral regurgitation grade 3 (moderate-severe) or more * prior surgical, transcatheter, or percutaneous mitral valve intervention * untreated clinically significant coronary artery disease (cad) requiring revascularization * hemodynamic instability: hypotension (systolic pressure \<90 mmhg) or requirement for inotropic support or mechanical hemodynamic support * any planned cardiac surgery or interventions within the next 6 months (including right heart procedures) * nyha class iv (i.e., non-ambulatory) * significant rv dysfunction (tapse \< 14) * severe tricuspid regurgitation * hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology * anatomical pathology or constraints preventing appropriate access/implant of the accucinch® ventricular repair system (e.g., femoral arteries will not support a 20f system) * renal insufficiency (i.e., egfr of \<30ml/min/1.73m2; stage 4 or 5 ckd) * moderate or severe aortic valve stenosis or regurgitation or aortic valve prosthesis * fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus or vegetation * active bacterial endocarditis * history of any stroke within the prior 3 months or modified rankin scale ≥ 4 disability from any prior stroke * subjects in whom anticoagulation or antiplatelet therapy is contraindicated * known allergy to nitinol, polyester, or polyethylene * any prior true anaphylactic reaction to contrast agents; defined as known anaphylactoid or other non-anaphylactic allergic reactions to contrast agents that cannot be adequately pre-medicated prior to the index procedure. * life expectancy \< 1 year due to non-cardiac conditions * currently participating in another interventional investigational study * implant or revision of any rhythm management device (crt or crt-d) prior 3 months or implantable cardioverter defibrillator within the prior 1 month * subjects on high dose steroids or immunosuppressant therapy * female subjects who are pregnant, of child bearing potential without a documented birth control method, or lactating